Clinical trial results are recorded in a clinical study report (CSR) in a prescribed manner; however, access to the CSR is usually limited. Summarised information from the CSR comes into the public domain via a number of routes.
Clinical trial results are statistically analysed in terms of demographics, efficacy, and safety. Different types of clinical trial may warrant different interpretations of trial results.
Phase III clinical studies, or confirmatory studies, are the final confirmation of the safety and efficacy of a medicine before it can be launched on the market. Phase III studies are the largest, most complicated, and most expensive part of the medicines development process, and nearly 50% of medicines that enter this phase will fail.
Phase I clinical studies, or proof of mechanism studies, test the safety of a medicine in humans. Usually, these studies are carried out in healthy human volunteers.
Researchers in clinical trials select sample populations from the whole patient population that the trial applies to, as it is not possible to run the clinical trial in the whole patient population. This is a standard statistical producedure. There are many things to consider in the selection of a sample population